MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M; HIP CERAMIC BALL HEAD

Model Number 01.29.209

Device Problem Output Problem (3005)

Patient Problem Unequal Limb Length (4534)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 september 2021: lot 2009404: (b)(4) items manufactured and released on 12-jan-2021.Expiration date: 2026-01-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

4 months after the primary surgery the patient came in reporting pain due to a leg length discrepancy and the cause is unknown.The surgeon revised the head and the surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M
• Type of Device: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12532782
• MDR Text Key: 273341261
• Report Number: 3005180920-2021-00782
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809200
• UDI-Public: 07630030809200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.29.209
• Device Catalogue Number: 01.29.209
• Device Lot Number: 2009404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention